Gulf Coast Regional Blood Center FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection NAI · Mar 31, 2026
  • No warning letters matched by name
Inspections 53 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Gulf Coast Regional Blood Center has 0 FDA recalls, 53 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gulf Coast Regional Blood Center" is on file.

What these totals cover: FDA records filed under the name "Gulf Coast Regional Blood Center".

Latest inspection
Mar 31, 2026 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections53Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Gulf Coast Regional Blood Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Gulf Coast Regional Blood Center: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202520000
202440000
202300000
202240000
202100000
202010000
201930000
201830000
201760000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

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Recent FDA inspections

53 inspections from Apr 23, 2009 to Mar 31, 2026. Showing the 20 most recent. View all 53 inspections

DateSiteProductClassificationFEI
Mar 31, 2026Houston, TXBiologicsNo Action Indicated (NAI)3003949974
Jun 27, 2025College Station, TXBiologicsNo Action Indicated (NAI)3006521863
Feb 28, 2025Houston, TXBiologicsNo Action Indicated (NAI)3002133806
Dec 9, 2024Nacogdoches, TXBiologicsNo Action Indicated (NAI)1627657
Oct 30, 2024Lufkin, TXBiologicsNo Action Indicated (NAI)3005096242
Jul 17, 2024The Woodlands, TXBiologicsNo Action Indicated (NAI)3005056388
Jul 12, 2024Cypress, TXBiologicsNo Action Indicated (NAI)3013944506
Nov 10, 2022Katy, TXBiologicsNo Action Indicated (NAI)3004723016
Sep 14, 2022Houston, TXBiologicsNo Action Indicated (NAI)3002133806
Sep 2, 2022Sugar Land, TXBiologicsNo Action Indicated (NAI)3003949984
Mar 24, 2022College Station, TXBiologicsNo Action Indicated (NAI)3006521863
Jan 31, 2020Houston, TXBiologicsNo Action Indicated (NAI)3003949974
Dec 11, 2019The Woodlands, TXBiologicsNo Action Indicated (NAI)3005056388
Jun 11, 2019Lufkin, TXBiologicsNo Action Indicated (NAI)3005096242
Jun 7, 2019Nacogdoches, TXBiologicsNo Action Indicated (NAI)1627657
Oct 16, 2018Cypress, TXBiologicsNo Action Indicated (NAI)3013944506
Aug 8, 2018Katy, TXBiologicsNo Action Indicated (NAI)3004723016
May 25, 2018Houston, TXBiologicsNo Action Indicated (NAI)3003949974
Dec 14, 2017The Woodlands, TXBiologicsNo Action Indicated (NAI)3005056388
Nov 7, 2017Sugar Land, TXBiologicsNo Action Indicated (NAI)3003949984
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

9 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3003949974Houston, TX7Mar 31, 2026
FEI 3006521863College Station, TX6Jun 27, 2025
FEI 3002133806Houston, TX6Feb 28, 2025
FEI 1627657Nacogdoches, TX7Dec 9, 2024
FEI 3005096242Lufkin, TX7Oct 30, 2024
FEI 3005056388The Woodlands, TX7Jul 17, 2024
FEI 3013944506Cypress, TX2Jul 12, 2024
FEI 3004723016Katy, TX5Nov 10, 2022
FEI 3003949984Sugar Land, TX6Sep 2, 2022

Gulf Coast Regional Blood Center and the FDA: common questions

Has Gulf Coast Regional Blood Center received an FDA warning letter?

No FDA warning letter addressed to the name "Gulf Coast Regional Blood Center" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Gulf Coast Regional Blood Center received an FDA Form 483?

FDA has not published a Form 483 for "Gulf Coast Regional Blood Center" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Gulf Coast Regional Blood Center?

The most recent FDA inspection on file ended Mar 31, 2026 at Houston, TX and was classified NAI. FDA has 53 inspections of Gulf Coast Regional Blood Center on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.